ProAir® HFA (albuterol sulfate) Inhalation Aerosol is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Information you should know

Who should not use ProAir® HFA?

What should I tell my doctor before I use ProAir® HFA? Before you use ProAir® HFA, tell your doctor if you:

Have heart problems

Have high blood pressure (hypertension)

Have convulsions (seizures)

Have thyroid problems

Have diabetes

Have low potassium levels in your blood

Are pregnant or plan to become pregnant. It is not known whether ProAir® HFA will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

Are breastfeeding or plan to breastfeed. It is not known whether ProAir® HFA passes into your breast milk. Talk to your doctor about the best way to feed your baby if you are using ProAir® HFA.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

ProAir® HFA, and other medicines, may affect each other and cause side effects. ProAir® HFA may affect the way other medicines work, and other medicines may affect the way ProAir® HFA works.

Especially tell your doctor if you take:

Other inhaled medicines or asthma medicines

Beta-blocker medicines

Diuretics

Digoxin

Monoamine oxidase inhibitors

Tricyclic antidepressants

Ask your doctor or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of them to show your doctor and pharmacist whenever you are prescribed a new medicine.

How should I use ProAir® HFA?

If your child needs to use ProAir® HFA, watch your child closely to make sure your child uses the inhaler correctly. Your doctor will show you how your child should use ProAir® HFA.

Each dose of ProAir® HFA should last up to four to six hours

Do not increase your dose or take extra doses of ProAir® HFA without first talking to your doctor

Get medical help right away if ProAir® HFA no longer helps your symptoms

Get medical help right away if your symptoms get worse, or if you need to use your inhaler more often

While you are using ProAir® HFA, do not use other inhaled rescue medicines unless your doctor tells you to do so

Call your doctor if your asthma symptoms, like wheezing and having trouble breathing, become worse over a few hours or days. Your doctor may need to give you another medicine (for example, corticosteroids) to treat your symptoms.

What are the possible side effects of ProAir® HFA? ProAir® HFA may cause serious side effects, including:

Worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). If this happens, stop using ProAir® HFA and call your doctor or get emergency help right away. Paradoxical bronchospasm is more likely to happen with your first use of a new canister of medicine.

Heart problems, including faster heart rate and higher blood pressure

Possible death in people with asthma who use too much ProAir® HFA

Allergic reactions. Call your doctor right away if you have the following symptoms of an allergic reaction:

Itchy skin

Swelling beneath your skin or in your throat

Rash

Worsening trouble breathing

Low potassium levels in your blood

Worsening of other medical problems, including increases in blood sugar

The most common side effects of ProAir® HFA include:

Your heart feeling like it is pounding or racing (palpitations)

Chest pain

Fast heart rate

Shakiness

Nervousness

Headache

Dizziness

Sore throat

Runny nose

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of ProAir® HFA. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store ProAir® HFA?

Store ProAir® HFA at room temperature, between 59°F and 77°F (15°C and 25°C)

Avoid exposure to extreme heat and cold

Shake the ProAir® HFA canister well before use

Do not puncture the ProAir® HFA canister

Do not store the ProAir® HFA canister near heat or flame. Temperatures above 120°F may cause the canister to burst

Do not throw the ProAir® HFA canister into a fire or an incinerator

Avoid spraying ProAir® HFA in your eyes

Keep ProAir® HFA and all medicines out of the reach of children.

General Information about the safe and effective use of ProAir® HFA:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ProAir® HFA for a condition for which it was not prescribed. Do not give ProAir® HFA to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information aboutProAir® HFA. If you would like more information, talk with your doctor. You can also see information about ProAir® HFA that has been written for health professionals by clicking on this link to the Prescribing Information.

For more information, call Teva Respiratory at 1-888-482-9522.

What are the ingredients in ProAir® HFA?

Active ingredient: albuterol sulfate

Inactive ingredients: propellant HFA-134a and ethanol

Have you heard? Find out about ProAir®'s other inhaler for patients 4 years of age and older.

Approved Uses

ProAir® HFA (albuterol sulfate) Inhalation Aerosol is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Important Safety Information

If your symptoms become significantly worse when you use ProAir® HFA, contact your doctor immediately. This may indicate either a worsening of your asthma or a reaction to the medication, which may rarely occur with the first use of a new canister of ProAir® HFA. Either of these could be life-threatening

What to tell your doctor before using ProAir® HFA: If you have a heart, blood, or seizure disorder, high blood pressure, diabetes, or an overactive thyroid, be sure to tell your doctor. Also make sure your doctor knows all the medications you are taking – especially heart medications and drugs that treat depression – because some medications may interfere with how well your asthma medications work. Do not exceed the recommended dose

Side effects associated with ProAir® HFA included headache, rapid heart beat, pain, dizziness, and irritation of the throat and nose

ProAir® HFA (albuterol sulfate) Inhalation Aerosol is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

OPEN

Important Safety Information

If your symptoms become significantly worse when you use ProAir® HFA, contact your doctor immediately. This may indicate either a worsening of your asthma or a reaction to the medication, which may rarely occur with the first use of a new canister of ProAir® HFA. Either of these could be life-threatening

The color red as used on the ProAir® HFA inhaler is a registered trademark of Teva Respiratory, LLC.

PRA-40851 March 2017

CLOSE

ProAir® HFA (albuterol sulfate) Inhalation Aerosol is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Important Safety Information

If your symptoms become significantly worse when you use ProAir® HFA, contact your doctor immediately. This may indicate either a worsening of your asthma or a reaction to the medication, which may rarely occur with the first use of a new canister of ProAir® HFA. Either of these could be life-threatening

What to tell your doctor before using ProAir® HFA: If you have a heart, blood, or seizure disorder, high blood pressure, diabetes, or an overactive thyroid, be sure to tell your doctor. Also make sure your doctor knows all the medications you are taking-especially heart medications and drugs that treat depression-because some medications may interfere with how well your asthma medications work. Do not exceed the recommended dose

Side effects associated with ProAir® HFA included headache, rapid heart beat, pain, dizziness, and irritation of the throat and nose